Natural Health Products Regulations

80 (1) Subject to subsection (2), the Minister may suspend the authorization to sell or import a natural health product for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that

• (a) the sponsor has contravened these Regulations or any provisions of the Act relating to the natural health product;

• (b) any information submitted or provided in respect of the natural health product or clinical trial is false or misleading;

• (c) the sponsor has failed to comply with good clinical practices; or

• (d) the sponsor has failed to

  • (i) provide information or samples of the natural health product as required under section 73 or 77, or

  • (ii) notify the Minister or provide a report under section 78.

(2) Subject to section 81, the Minister shall not suspend the authorization unless

• (a) the Minister has sent the sponsor a notice that indicates whether the authorization is intended to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension; and

• (b) the sponsor has not, within 30 days after the day on which the notice referred to in paragraph (a) is received, provided the Minister with information or documents demonstrating that the authorization should not be suspended on the grounds that

  • (i) the situation giving rise to the intended suspension did not exist, or

  • (ii) the situation giving rise to the intended suspension has been corrected.